Binax, Inc.

FDA 510(k) & PMA Approved Devices — 30 products

Total Devices30

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K090301	BINAXNOW PBP2A TEST, MODEL 890-000	MYI	2010-04-14	View
510(k)	K091766	CLEARVIEW EXACT PBP2A TEST, MODEL 891-000	MYI	2010-02-24	View
510(k)	K090964	BINAXNOX STAPHYLOCOCCUS AUREUS TEST	JWX	2009-12-16	View
510(k)	K091489	CLEARVIEW ADVANCED STREP A , MODEL 737-430	GTY	2009-09-04	View
510(k)	K083744	BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010	MJZ	2009-09-01	View
510(k)	K092223	MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST	PSZ	2009-08-12	View
510(k)	K080003	BINAXNOW G6PD TEST	JBF	2008-10-23	View
510(k)	K062109	BINAXNOW INFLUENZA A & B TEST	PSZ	2006-11-09	View
510(k)	K053126	BINAXNOW INFLUENZA A & B TEST	PSZ	2005-11-30	View
510(k)	K041049	BINAXNOW INFLUENZA A & B TEST	PSZ	2004-08-10	View
510(k)	K032166	BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065	GQG	2003-10-21	View
510(k)	K021646	BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK	PSZ	2002-09-19	View
510(k)	K021649	BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK	PSZ	2002-09-19	View
510(k)	K021687	BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK	GQG	2002-09-13	View
510(k)	K012521	BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST	GTZ	2001-11-30	View
510(k)	K010523	MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST	GTZ	2001-03-15	View
510(k)	K991726	BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI	GTZ	1999-08-27	View
510(k)	K982238	BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522	MJH	1998-08-21	View
510(k)	K960712	BINAX STREP A TEST	GTZ	1996-03-22	View
510(k)	K934965	BINAX LEGIONELLA URINARY ANTIGEN EIA	MJH	1994-09-20	View